EP0885025B1 - System for holding and delivering a solution - Google Patents

System for holding and delivering a solution Download PDF

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Publication number
EP0885025B1
EP0885025B1 EP97942635A EP97942635A EP0885025B1 EP 0885025 B1 EP0885025 B1 EP 0885025B1 EP 97942635 A EP97942635 A EP 97942635A EP 97942635 A EP97942635 A EP 97942635A EP 0885025 B1 EP0885025 B1 EP 0885025B1
Authority
EP
European Patent Office
Prior art keywords
chambers
solution
container
patient
fluid communication
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP97942635A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0885025A1 (en
Inventor
Ying-Cheng Lo
Marc Bellotti
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc filed Critical Baxter International Inc
Publication of EP0885025A1 publication Critical patent/EP0885025A1/en
Application granted granted Critical
Publication of EP0885025B1 publication Critical patent/EP0885025B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1668—Details of containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/1686—Sterilisation or cleaning before or after use by heat
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/24—Medical-surgical bags

Definitions

  • the present invention generally relates to a system for holding and dispensing a solution. More specifically, the present invention relates to a system for delivering a solution to a patient undergoing peritoneal dialysis as well as draining a peritoneum of the patient.
  • a first container or drain bag
  • a second container or solution container
  • the dialysate is delivered via the tubing from the solution bag to the peritoneum of the patient.
  • WO-A-83/02061 describes a solution bag formed of three plastic walls sealed together about their peripheries to define a pair of separate chambers.
  • the known procedure is complex in that a number of components and additional steps are often required to perform the procedure. More specifically, at least a solution bag, a drain bag, tubing extending from each of the bags, connectors, at least one frangible, and caps on the connectors are required to perform CAPD using a two bag system.
  • a system for holding and administering a solution according to claim 1.
  • the system comprises a container that holds the solution for delivery, for example, to a patient undergoing peritoneal dialysis, and also is capable of receiving solution separately from the area in which the solution is held.
  • a system for holding and administering a solution.
  • the system has a container having walls defining an interior holding the solution therein wherein the container is divided into two chambers in fluid communication therewith and further wherein the two chambers are substantially parallel to each other and are of substantially equal length.
  • a separation line is formed between the two chambers along substantially the length of each of the two chambers.
  • a port is provided which is in fluid communication with the two chambers.
  • an aperture is provided at one end of one of the two chambers to suspend the chamber.
  • the lengths of the two chambers are substantially greater than the widths.
  • a medication port is provided in fluid communication with the two chambers.
  • volume of one of the two chambers is greater than volume of the other one of the two chambers.
  • volume of one of the two chambers is at least 1.5 times greater than volume of the other one of the two chambers.
  • the solution may be delivered to the patient without additional tubing.
  • a method of delivering a solution to a patient may comprise the steps of: providing a container having an interior holding a solution wherein the container is divisible into two chambers; providing a port in fluid communication with each of the two chambers; sealing a portion of the container to separate the solution into only one of the two chambers; and connecting the port to the patient to provide fluid communication with the patient.
  • the method may further comprise the step of connecting a length of tubing between the port and the patient.
  • a medication port is provided in fluid communication with the two chambers.
  • the method also may further comprise the step of suspending one of the two chambers through an aperture at one end of the chamber.
  • the method may further comprise the step of separating the two chambers along a length of the two chambers such that one chamber is substantially sealed from the other chamber.
  • the method may further comprise the step of separating the two chambers along a line of separation extending substantially along a length between the two chambers wherein the line of separation may be selectively broken to separate the two chambers along the line of separation.
  • one of the two chambers has a volume greater than the other one of the two chambers.
  • the tear line is selectively separable to divide the first chamber from the second chamber and maintain fluid communication between the first chamber and the second chamber.
  • Another advantage of the present invention is to provide a system for administering a solution to a patient that is simple to manufacture.
  • Yet another advantage of the present invention is to provide a system that may be used as both the solution bag and the drain bag.
  • Another advantage of the present invention is to provide a system that administers solution to a patient without requiring additional tubing.
  • an advantage of the present invention is to provide a system that is easily separable between two separate chambers prior to use.
  • a still further advantage of the present invention is to provide a system that administers solution to a patient without priming of tubing.
  • Yet another advantage of the present invention is to provide a system in which sticking of film materials is eliminated during sterilization.
  • Another advantage of the present invention is to provide a system that requires shorter sterilization times with more uniform temperature distribution in the bag.
  • the present invention provides a system for holding and delivering a solution.
  • the container used in the system of the present invention is multi-chambered having interiors holding a solution.
  • the solution may be manipulated from one chamber to another during use of the system to perform the method of the present invention.
  • Figure 1 illustrates a system 1 including a container 10 having a solution 12 within an interior 14 of the container 10.
  • the container 10 is divided into a solution side 16 and a drain side 18 separated by a tear line 20.
  • the solution side 16 and the drain side 18 are in fluid communication at an end 22 of the container 10 through a channel 23 such that the solution 12 within the container 10 may be isolated on either the solution side 16 or the drain side 18.
  • an aperture 26 At an opposite end 24 of the container 10 on the solution side 16 is an aperture 26 whose function will be described with reference to Figures 2 and 3.
  • a port 28 In fluid communication with the container 10 is a port 28. Also provided is an optional medication port 30 used to provide medication to the interior 14 of the container 10, if necessary.
  • the port 28 may be connected to a length of tubing 32. Alternatively, the port 28 may be connected directly to a device connected to a patient that provides fluid communication with, for example, a peritoneum cavity of the patient.
  • the drain side 18 of the container 10 is larger in volume than the solution side 16.
  • the drain side 18 has a volume at least 1.5 times greater than the solution side 16.
  • the walls of both the solution side 16 and the drain side 18 are preferably tapered as illustrated in Figure 1.
  • the channel 23 formed at the end 22 of the container 10 allows the solution 12 to freely flow from either the solution side 16 or the drain side 18 of the container 10.
  • the channel 23 is formed between a terminating end 34 of the tear line 20 and the end 22 of the container 10.
  • the tear line 20 is formed by a sealing technique well-known by those skilled in the art.
  • the tear line 20 is formed substantially simultaneously with the formation of the walls of the container 10.
  • the solution 12 within the container 10 is first transferred to the solution side 16 of the container 10. Therefore, prior to draining of the peritoneum cavity of the patient 35, the drain side 18 is substantially empty through isolation of the solution 12 on the solution side 16 of the container 10.
  • a clamp 36 is placed at a point to separate the port 28 from the solution 12.
  • the tear line 20 is torn to separate the solution side 16 from the drain side 18.
  • the solution side 16 may be suspended by a hook (38) or other known means through the aperture 26 at the end of the drain side 18 of the container 10 as illustrated.
  • the peritoneum of the patient 35 is then drained into the drain side 18 of the container 10.
  • the clamp 36 may be moved to the position illustrated in Figure 3.
  • a second clamp is placed in the position illustrated in Figure 3 and then the clamp 36 illustrated in the position in Figure 2 is removed from the solution side 16.
  • the drain side 18 is at least partially filled with drainage from the peritoneum cavity of the patient 35 as generally designated by 40 in Figures 2 and 3.
  • the solution 12 in the solution side 16 of the container 10 may be drained through the port 28 into the peritoneum cavity of the patient 35.
  • a tubing 32 is illustrated connected between the port 28 and the peritoneum cavity of the patient 35.
  • the port 28 may be directly connected to a connecting device (not shown) that, in turn, is connected to the peritoneum cavity.
  • the container 10 may be disconnected from the patient 35.
  • a system 100 includes a container 110 having a solution 112 located within the interior 114 of the container 110. This tube can be obtained from blown film process.
  • the interior of the container 110 is divided into a solution side 116 and a drain side 118.
  • a clamp or clamps (not shown) may be placed across a width of the container 110 in positions that maintain the solution 112 on the solution side 116 during draining of the peritoneum cavity into the drain side 118 through a port 120.
  • a second clamp may be placed across a width of the container 110 to maintain the drainage from the peritoneum cavity on the drain side 118.
  • the first clamp may be removed to allow draining of the solution 112 from the solution side 116 into the peritoneum cavity.
  • the container 110 may include an aperture on the solution side 116 such that the system 100 may be suspended similar to the manner illustrated in Figures 2 and 3.
  • FIG. 5 another alternate embodiment of a system 200 is illustrated with a container 210 having a solution 212 within an interior 214 of the container 210.
  • the container 210 includes a solution side 216 and a drain side 218.
  • the solution side 216 and the drain side 218 are divided by a tear line 220.
  • the solution side 216 and the drain side 218 are separated at the tear line 220.
  • a clamp (not shown) may be placed at a point across a width of the solution side 216 to maintain or isolate the solution 212 on the solution side 216 and to prevent fluid communication of the solution 212 through a port 222.
  • a peritoneum cavity of a patient may then be drained through the port 222 into the drain side 218 of the container 210.
  • a second clamp may then be placed at a point across a width of the drain side 218 to prevent fluid communication of the drainage from the patient between the drain side 218 and the port 222.
  • the first clamp may then be removed, and the solution side 216 may be drained of the solution 212 from the solution side 216 of the container 210 into the peritoneum cavity of the patient.
  • containers may from a flexible material, such as polyvinyl chloride (PVC), other materials may be implemented by those skilled in the art, such as non-PVC materials.
  • PVC polyvinyl chloride

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • External Artificial Organs (AREA)
EP97942635A 1996-09-27 1997-09-22 System for holding and delivering a solution Expired - Lifetime EP0885025B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US722537 1996-09-27
US08/722,537 US5876396A (en) 1996-09-27 1996-09-27 System method and container for holding and delivering a solution
PCT/US1997/016777 WO1998013079A1 (en) 1996-09-27 1997-09-22 System, method and container for holding and delivering a solution

Publications (2)

Publication Number Publication Date
EP0885025A1 EP0885025A1 (en) 1998-12-23
EP0885025B1 true EP0885025B1 (en) 2003-11-26

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP97942635A Expired - Lifetime EP0885025B1 (en) 1996-09-27 1997-09-22 System for holding and delivering a solution

Country Status (9)

Country Link
US (2) US5876396A (ko)
EP (1) EP0885025B1 (ko)
JP (1) JP2000501326A (ko)
KR (1) KR19990071650A (ko)
BR (1) BR9706775A (ko)
DE (1) DE69726411T2 (ko)
ES (1) ES2212130T3 (ko)
MX (1) MX9804140A (ko)
WO (1) WO1998013079A1 (ko)

Cited By (4)

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US9066777B2 (en) 2009-04-02 2015-06-30 Kerr Corporation Curing light device
US9726435B2 (en) 2002-07-25 2017-08-08 Jonathan S. Dahm Method and apparatus for using light emitting diodes for curing

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JP2000501326A (ja) 2000-02-08
US5876396A (en) 1999-03-02
WO1998013079A1 (en) 1998-04-02
BR9706775A (pt) 1999-04-13
US5865793A (en) 1999-02-02
EP0885025A1 (en) 1998-12-23
DE69726411T2 (de) 2004-09-09
KR19990071650A (ko) 1999-09-27
MX9804140A (es) 1998-09-30
ES2212130T3 (es) 2004-07-16

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